510(k) submissions
Filtered by Hair removal · showing 1–50 of 176
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)Hair removal | Leaseir Technologies, SluSpain | Diode | Class 2 | 2026-05-04 |
| K260307 | Diode Laser Therapy Systems (V19)Hair removal | Weifang Mingliang Electronics Co., Ltd.China | Diode | Class 2 | 2026-04-15 |
| K253828 | Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Hair removal | Beijing HuaCheng Taike Technology Co., Ltd.China | Alexandrite | Class 2 | 2026-02-27 |
| K252599 | Diode Laser Therapy Systems (WLA-02)Hair removal | Wingderm Electro-Optics , Ltd.China | Diode | Class 2 | 2026-02-24 |
| K252048 | 808nm semiconductor laser hair removal machineHair removal | Xi'An Taibo Electronic Technology Co., Ltd.China | Diode | Class 2 | 2026-02-03 |
| K252753 | Vydence Family of LasersHair removal | Vydence Medical Industria E Commercio LtdaBrazil | Nd:YAG | Class 2 | 2026-01-24 |
| K252877 | SANDRO DualHair removal | Wontech Co., Ltd.Korea, Republic of | Alexandrite | Class 2 | 2025-12-19 |
| K253344 | BELLUS-QSurgical cutting | Speclipse, Inc.Korea, Republic of | Q-Switched | Class 2 | 2025-11-25 |
| K252515 | Q-Switched Nd:Yag laser (K690)Pigment treatment | Hebei Keylaser Sci-Tech Co.,LtdChina | Nd:YAG | Class 2 | 2025-11-06 |
| K252427 | Diode Laser Hair Removal Machine (GLD01)Hair removal | Sanhe Meditech Co., Ltd.China | Diode | Class 2 | 2025-10-31 |
| K242859 | VEGAHair removal | Ibramed Equipamentos MédicosBrazil | Diode | Class 2 | 2025-09-19 |
| K251457 | Diode laser therapy device (VADER)Hair removal | Beijing Superlaser Technology Co., Ltd.China | Diode | Class 2 | 2025-09-03 |
| K251801 | Diode laser device (BM091)Hair removal | Hebei Newangie Technology Co., Ltd.China | Diode | Class 2 | 2025-08-08 |
| K251076 | Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Hair removal | Shenzhen Lifotronic Technology Co., Ltd.China | Diode | Class 2 | 2025-07-30 |
| K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)Hair removal | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | Diode | Class 2 | 2025-07-25 |
| K250165 | PastelleSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2025-07-03 |
| K251329 | Diode laser device (RF3120-BI)Hair removal | Risu Medical Technology Co., Ltd.China | Diode | Class 2 | 2025-06-27 |
| K251632 | Optimas MAX SystemHair removal | InMode , Ltd.France | Diode | Class 2 | 2025-06-26 |
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico DermPigment treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2025-06-06 |
| K250431 | Medical Diode Laser Hair Removal System (MNLT-D1)Hair removal | Shandong Moonlight Electronics Tech Co., Ltd.China | Diode | Class 2 | 2025-05-12 |
| K242951 | Diode laser hair removal machine (QDTM-02)Hair removal | Beijing Nubway S&T Co., Ltd.China | Diode | Class 2 | 2025-04-28 |
| K250206 | Diode laser system (Night Universe; Predator)Hair removal | Ivylaser (Beijing) Technology Co.,LtdChina | Diode | Class 2 | 2025-04-24 |
| K250809 | Stellar M22Hair removal | Lumenis Be, Ltd.Israel | Nd:YAG | Class 2 | 2025-04-16 |
| K243044 | Alma HarmonyHair removal | Alma Lasers, Inc.United States | Nd:YAG | Class 2 | 2025-04-11 |
| K250018 | Medical Diode Laser Systems (THEIA808)Hair removal | Gigaalaser Company , Ltd.China | Diode | Class 2 | 2025-04-01 |
| K243630 | Medical Laser System Incanto / Evoline Platinum /EvolineHair removal | Solar LS CjscBelarus | Alexandrite | Class 2 | 2025-03-21 |
| K243780 | HELIOS 785 Pico (1754V2)Pigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2025-02-07 |
| K243465 | Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)Hair removal | Guangzhou Chuang Zao Mei Technology Co., Ltd.China | Diode | Class 2 | 2025-02-06 |
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Hair removal | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2024-12-30 |
| K241498 | Diode laser Treatment System (K18)Hair removal | Hebei Keylaser Sci-Tech Co.,LtdChina | Diode | Class 2 | 2024-11-18 |
| K241951 | Lasya-TrinityHair removal | BLUECORE COMPANY Co., Ltd.Korea, Republic of | Diode | Class 2 | 2024-10-10 |
| K241860 | Diode Laser Hair Removal SystemHair removal | Beijing Winkonlaser Technology LimitedChina | Diode | Class 2 | 2024-09-25 |
| K242349 | FoLixHair removal | Lumenis Be, Ltd.Israel | Other | Class 2 | 2024-09-09 |
| K241547 | Diode Laser Therapy Device (DF-DIODE LASER-S1)Hair removal | Weifang Dragonfly Electronics Technology Co., Ltd.China | Diode | Class 2 | 2024-08-13 |
| K241656 | Eneka SelectifHair removal | TermosaludSpain | Alexandrite | Class 2 | 2024-08-12 |
| K231950 | MEDIDIODEHair removal | Medicreations, LLCUnited States | Diode | Class 2 | 2024-08-09 |
| K241642 | Diode Laser Hair Removal System (MBT-Diode Laser)Hair removal | Beijing Mega Beauty Technology Co., Ltd.China | Diode | Class 2 | 2024-08-02 |
| K241459 | MOTUS PRO FamilyHair removal | El.En S.P.A.Italy | Diode | Class 2 | 2024-06-21 |
| K240611 | IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Hair removal | Ivylaser (Beijing) Technology Co.,LtdChina | Diode | Class 2 | 2024-06-20 |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Hair removal | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2024-06-14 |
| K240874 | Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)Hair removal | Theralaser Medtech (China) Co., Ltd.China | Diode | Class 2 | 2024-05-28 |
| K240520 | Diode Laser Hair Removal System (SH-VD910)Hair removal | Beijing Sea Heart International Science and Technologyco.LtdChina | Diode | Class 2 | 2024-05-20 |
| K240474 | Multi-function Platform Systems (BL-M10)Hair removal | Shanghai Bele Medical Technology Co.,LtdChina | Nd:YAG | Class 2 | 2024-05-20 |
| K240752 | DEKA TOROPigment treatment | El.En S.P.A.Italy | Q-Switched | Class 2 | 2024-05-16 |
| K240816 | MeDioStarHair removal | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2024-04-23 |
| K234057 | NIRVANAHair removal | El.En S.P.A.Italy | Diode | Class 2 | 2024-04-10 |
| K240396 | Elite iQ PRO (M122K1)Hair removal | Cynosure, LLCUnited States | Alexandrite | Class 2 | 2024-03-08 |
| K231896 | Diode Laser Therapy SystemHair removal | Beijing Adss Development Co., Ltd.China | Diode | Class 2 | 2024-02-20 |
| K233756 | Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)Hair removal | Rhein Laser Technologies Co., Ltd.China | Diode | Class 2 | 2024-02-02 |
| K231910 | DermRays ReviveHair removal | Wuhan Lotuxs Technology Co., Ltd.China | Diode | Class 2 | 2024-01-30 |
